UMIN-CTR Clinical Trial

Basic information
Public title	Functional image-guided intensity-modulated radiotherapy for unresectable locally advanced lung cancer
Acronym	FIGURE study
Scientific Title	A phase II study of functional image-guided intensity-modulated radiotherapy for unresectable locally advanced lung cancer
Scientific Title:Acronym	FIGURE study
Region	Japan

Condition
Condition	non-small cell lung cancer
Classification by specialty	Pneumology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To prospectively investigate the safety and efficacy of functional image-guided intensity-modulated radiation therapy(IMRT) in patients with unresectable stage IIB-IIIC non-small cell lung cancer, and show whether Grade 3 or higher radiation pneumonitis become less frequent.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	The incidence of Grade 3 or higher radiation pneumonitis(Common Terminology Criteria for Adverse Events ; CTCAE ver. 5.0) within 1 year after IMRT.
Key secondary outcomes	overall survival, progression-free survival, Grade 3 or higher adverse effects other than radiation pneumonitis, the relationship between dose-volume histogram(DVH) parameters and Grad 2, 3 or higher radiation pneumonitis, pulmonary function at 1 year after IMRT

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Functional image-guided IMRT 60-66Gy in 30-33 fractions
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Histologically or cytologically confirmed Non small cell lung cancer 2. Unresectable or refusing surgery 3. Clinical stage IIB-IIIC (UICC 8th edition) 4. Aged 20-85 years old. 5. Eastern Cooperative Oncology Group(ECOG) performance status of 0-2. 6. No previous tehrapy, such as chemotherapy, surgery, radion therapy, immune therapy for lung cancer. 7. Sufficient organ functions; fulfilling all of the following conditions within 28 days; (i) White blood cell:3000/mm3 or more (ii) Hemoglobin:8.0 g/dl or more (iii) Platelet:50000/mm3 or more (iv) Total bilirubin:2.0 mg/dl or less (v) Serum creatinine:2.0 mg/dl or less (vi) FEV1.0:700 ml or more (vii) SpO2 (room air):90% or more 8. Written informed consent.
Key exclusion criteria	1. Synchronous or metachronous (within 3 years) malignancies. 2. Active infection requiring systemic therapy. 3. Body temperature of 38 or more degrees Celsius. 4. Women during pregnancy or possible pregnancy, within 28 days after delivery, or during breast feeding. 5. Severe mental disease. 6. Receiving continuous systemic steroid or immune-suppressive medication. 7. Idiopathic pulmonary fibrosis on CT. 8. Severe cough requiring narcotic drugs.
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Tomoki Middle name Last name Kimura
Organization	Kochi University Hospital
Division name	Radiation Oncology
Zip code	783-8505
Address	Kohasu, Oko-cho, Nangoku-shi, Kochi
TEL	088-880-2367
Email	tkkimura@kochi-u.ac.jp

Public contact
Name of contact person	1st name Nobuki Middle name Last name Imano
Organization	Hiroshima University Hospital
Division name	Radiation Oncology
Zip code	734-8551
Address	1-2-3, Kasumi, Minami-ku, Hiroshima
TEL	082-257-1545
Homepage URL
Email	imano@hiroshima-u.ac.jp

Sponsor
Institute	Kochi University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and technology of Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Hiroshima University
Address	1-2-3, Kasumi, Minami-ku, Hiroshima
Tel	082-257-5555
Email	iryo-seisaku@office.hiroshima-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2019 Year 10 Month 24 Day
Date of IRB	2019 Year 10 Month 24 Day
Anticipated trial start date	2019 Year 11 Month 01 Day
Last follow-up date	2027 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 25 Day
Last modified on	2021 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043490